Healthy Skepticism Library item: 14522

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Publication type: news

Taylor L.
EU Parliament OKs plan to simplify rules on changes to medicines
Pharma Times 2008 Oct 24
http://www.pharmatimes.com/WorldNews/article.aspx?id=14605&src=EWorldNews

Full text:

The European Parliament has backed proposals by the Commission which would make all medicines on the market in Europe subject to a single set of rules for making changes to the terms of their marketing authorisations.

The European Union (EU) Variations Regulations for making such changes currently do not apply to products which have gone through the national member state approval route, so changes made to these products after they have arrived on the market – such as new production processes or packaging, or an update of the patient information leaflet (PIL) – w have to be dealt with under national rules, which vary widely throughout the EU.

Under the proposed Directive, which has already been approved by the member states, all medicines on the market will be subject to the same criteria for the approval and administrative handling of changes. This streamlined procedure will cut costs, time and bureaucracy and speed innovation without compromising public health, say its supporters.

Parliament’s approval has been welcomed by both the Commission and industry spokesmen. Guenter Verheugen, Commission Vice President and Commissioner for Enterprise and Industry which is responsible for the pharmaceutical industry, said that the current legislation presents a “huge burden” in terms of costs and time and that while medicines have to be constantly developing, the costs involved in the registration procedure have been too high. “We can’t accept this,” stated the Commissioner.

“Reducing the existing bureaucracy around these variations will encourage industry to make continual improvements to their products, which can only be a benefit to Europe’s patients,” added Brian Ager, director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA).